Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Total hip replacement is indicated in the following conditions:

Severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

The AML® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as for cemented use and fixation in which the porous coating serves as a bonding surface of the prostheses to the bone cement.

Device Description

The AML hip stem is manufactured from ASTM F-75 Cobalt-Chromium-Molybdenum alloy and has a cobalt-chrome-molybdenum alloy bead sintered porous coating (Porocoat®) applied to the stem. The porous coating is applied to the entire stem with the exception of the tapered stem tip region.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (AML® Hip Prosthesis), which is a premarket notification for a Class II medical device to show that it is substantially equivalent to a legally marketed predicate device. This type of submission is not a clinical study where acceptance criteria, performance metrics, and detailed study methodologies are typically presented as they would be for a new or novel device requiring extensive clinical validation.

Instead, the submission focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means the manufacturer is asserting that the new device has the same intended use, technological characteristics, and safety and effectiveness profile as previously cleared devices, and therefore does not require a new premarket approval (PMA) application with extensive clinical trials.

Therefore, the requested information for acceptance criteria and a study proving the device meets those criteria cannot be directly extracted from this document in the traditional sense of a clinical trial report.

However, I can extract the relevant information regarding the basis for acceptance and equivalence, and explain why the study details you're looking for aren't present in this type of regulatory document.

Here's an analysis based on the provided text, addressing your points where possible and explaining limitations:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: In a 510(k) submission, the "acceptance criteria" are not performance metrics in the way a clinical study would define them (e.g., sensitivity, specificity, accuracy). Instead, the primary acceptance criterion for clearance is demonstrating substantial equivalence to legally marketed predicate devices. This is achieved by showing similarities in:
- Intended Use
- Indications for Use
- Technological Characteristics (e.g., design, materials, manufacturing processes)
- Safety and Effectiveness profile
Reported Device Performance: The document does not report specific device performance metrics from a dedicated clinical study but rather states the intended functions and relies on the established safety and effectiveness of the predicate devices.

2. Sample size used for the test set and the data provenance

Not Applicable: This document does not describe a clinical study with a "test set" or explicit "data provenance" in the context of clinical performance evaluation. The substantial equivalence argument typically relies on:
- Bench testing: To demonstrate material properties, mechanical strength, and other physical characteristics are comparable to predicate devices. While not explicitly detailed here, these tests are standard for orthopedic implants.
- Pre-clinical testing: Biocompatibility and other non-clinical assessments, again, generally compared against established standards or predicate device data.
- Historical clinical data: The proven track record of the predicate devices in patient populations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: "Ground truth" in the context of clinical outcomes derived from expert consensus is not part of a 510(k) submission for substantial equivalence. The "ground truth" for regulatory clearance is the established safety and efficacy of the predicate devices, as determined by prior FDA clearances and market experience.

4. Adjudication method for the test set

Not Applicable: Since no clinical "test set" and outcome adjudication are described, this point does not apply.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: This is an orthopedic implant for hip replacement, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are entirely irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable: As stated above, this is an orthopedic implant and does not involve algorithms or human-in-the-loop performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Indirect Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices:
- Porocoat® Prodigy™ Hip Prosthesis (K931641)
- Vision AML® Hip Prosthesis (K953694)
- This "ground truth" is based on the long-term clinical outcomes and regulatory clearances of these previously marketed devices, which would have had their own validation data (which may or may not include expert consensus, pathology, or outcomes data depending on their original approval pathway). The applicant demonstrates that their new device is fundamentally similar enough to these predicates that it can be presumed to be equally safe and effective.

8. The sample size for the training set

Not Applicable: This submission does not involve machine learning or a "training set" in the computational sense. The "training" for such an application would be the cumulative experience and performance data of the predicate devices over their market lifespan, but no specific "sample size" is reported here for this purpose.

9. How the ground truth for the training set was established

Not Applicable: As there is no "training set" in the context of this 510(k) for an orthopedic implant, this question does not apply.

Summary of Device Acceptance for the AML® Hip Prosthesis:

The device's acceptance by the FDA, as indicated by the 510(k) clearance (K003800), is based on the demonstration of substantial equivalence to existing, legally marketed predicate devices. The study proving this "meets acceptance criteria" is the comprehensive 510(k) submission itself, which details the comparison between the AML® Hip Prosthesis and its predicate devices across several key areas:

Predicate Devices: Porocoat® Prodigy™ Hip Prosthesis (K931641) and Vision AML® Hip Prosthesis (K953694).
Basis for Equivalence:
- Identical Intended Use: To provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation.
- Identical Indications for Use: Including severe pain from arthritis, avascular necrosis, acute traumatic fracture, failed previous hip surgeries, and certain cases of ankylosis.
- Similar Design & Materials: Manufactured from ASTM F-75 Cobalt-Chromium-Molybdenum alloy with a cobalt-chrome-molybdenum alloy bead sintered porous coating (Porocoat®). The design "resembles" the predicate.
- Identical Sterilization Processes: Ensuring comparable safety in preparation for use.
- Established Safety & Effectiveness of Predicates: The assumption is that because the new device is "substantially equivalent" in design, materials, and intended use, it will have a comparable safety and effectiveness profile to the already cleared predicate devices.

The FDA's review of this submission concluded that the AML® Hip Prosthesis is substantially equivalent to the identified predicate devices, allowing it to be legally marketed. This process does not typically involve new, extensive clinical trials validating specific performance metrics for the new device itself beyond what's required to show equivalence.

Summary

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FEB - 9 2001

KOO3800 10-2

510(k) Summary

Name of Sponsor:

510(k) Contact:

Trade Name:

Common Name:

Classification:

Device Product Code:

Substantially Equivalent Device:

Device Descriptions:

Intended use:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Est. Reg. No. 1818910

Marcia J. Arentz Senior Regulatory Associate Phone: (219) 371-4944 FAX: (219) 371-4940

AML® Hip Prosthesis

Total Hip Joint Replacement Prosthesis with porous coating

Class II Device per 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis

Code: 87LPH Prosthesis Hip Semi-constrained, Metal/Polymer, Porous Uncemented No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems.

Porocoat® Prodigy™ Hip Prosthesis K931641 Vision AML® Hip Prosthesis K953694

000005

{1}------------------------------------------------

K003800
2 OF 2

510(k) Summary (continued)

Indications for use:

Total hip replacement is indicated in the following conditions:

Severely painful and/or disabled joint from l. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head. 2.
Acute traumatic fracture of the femoral head or 3. neck.
Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis. 5.

Based on similarities of design, commonly used materials, identical sterilization processes, the same indications for use and intended use, DePuy believes that the modified AML Hip Prosthesis is substantially equivalent to the FDA cleared Prodigy Hip Prosthesis system (K931641) and the Vision AML Hip System (K953694).

Substantial equivalence:

0000000

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image. The text is in all caps and appears to be in a sans-serif font.

FEB = 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K003800

Trade Name: AML® Hip Prosthesis Regulatory Class: II Product Code: LPH Dated: December 7, 2000 Received: December 8, 2000

Dear Ms. Arentz:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the encrosure) to device Amendments, or to devices that have been reclassified in chacultion unto of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general therefore, market the device, bac) be requirements for annual registration, listing of devices, control provisions of the labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remanot ripped any in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspotions, and regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

{3}------------------------------------------------

Page 2 - Ms. Marcia J. Arentz

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and II you desire specific articles your dones contact the Office of Compliance at additionally 607.10 for in viro daglestions on the promotion and advertising of your device, (201) 594-4637. Traditional), 18. quise at (301) 594-4639. Also, please note the regulation
10.01. prease connact the Ornec or Compitance as (2011) of the 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small
information on your responsibilities under the Act 12011 110 (6607 monifacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerery, yours,

Mark M Melkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known)v/ 00 3800

Device Name: AML Hip Prosthesis

Indications for Use:

Total hip arthroplasty is intended to provide increased patient mobility and reduce paint by replacing I otal hip artifically is thended to provide were is evidence of sufficient sound bone to seat
the damaged hip joint articulation in patients where there is evidence of suffi the damaged hip John articulation in patichis where in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid 1. arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head. 2.
Acute traumatic fracture of the femoral head or neck. 3.
Acule fraumatic fracture of the remoral nead or internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis. ર.

The AML® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth I he AML "Hip Stelli is indication for cemented use and fixation in which the porous coating serves as mto the porous counting as woon of the prostheses to the bone cement.

Concurrence of CDRH, Office of Device Evaluation

Mark M. Mulkerson

(Division Sign-Off) Division of General, Pestorative and Neurological Devices

KOO3800 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.